A Single Center, Open, Randomized Clinical Trials, Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Total Mesorectal Excision for Middle and Low Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Postoperative complication
研究概览
简要总结
The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical resection of rectal carcinoma). This study was expected to demonstrate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.
详细描述
A temporary stoma may, in fact, result in reduced quality of life because of feelings of physical and mental restriction, debilitating nuisance, among other problems. Skin irritation, prolapse, and retractionare quite common after ileostomy. A high incidence of parastomal hernia, ileus, and increased salt and fluid loss has been reported, which may also contribute to greater willingness of both the surgeon and patient to close the temporary stoma as soon as possible.
Currently, it remains unclear whether stoma closure should be performed after the end of chemotherapy or during chemotherapy (12 weeks or 24 weeks after radical resection of rectal carcinoma).
The aim of this study is to assess the possible impact of stoma closure timing on postoperative results and to evaluate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sign the informed consent
- •postoperative pathology is rectal adenocarcinoma
- •primary middle and low rectal cancer patients (tumor distance from the anal margin is less than 10 cm)
- •underwent total mesorectal excision for rectal cancer with preventive loop ileostomy
排除标准
- •postoperative pathology is not rectal adenocarcinoma (rectal neuroendocrine tumor, lymphoma, etc.)
- •postoperative pathologic staging of rectal cancer is I phase, II phase
- •underwent total mesorectal excision for rectal cancer without preventive loop ileostomy
- •emergency operation for rectal cancer
- •disease progression (local recurrence or distant metastasis, etc.)
- •anastomotic stenosis
- •serious system disease, including heart dysfunction, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases
- •participate in other clinical trial
- •pregnancy or perinatal woman
- •combined with other malignant tumor
- •with a history of neurological and psychiatric disorders
- •patients with abnormal bone marrow suppression after chemotherapy
研究组 & 干预措施
stoma closure at different times
choose different times to do stoma closure after surgery for rectal cancer
干预措施: stoma closure at different times (Procedure)
结局指标
主要结局
Postoperative complication
时间窗: within the first 2 weeks after surgery
次要结局
- Disease-free survival(five years)
- Postoperative quality of life(five years)
- survival rate(five years)